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Glaucoma Drainage Device and Endothelial Cell Loss Compare Trial
NCT05924477 · University of Pennsylvania
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this study
The DECLARE Trial is a prospective 1:1 randomized, parallel design, double-masked clinical trial to compare endothelial cell density (ECD), intraocular pressure (IOP) and metagenomic RNA deep sequencing (MDS) between sulcus and anterior chamber (AC) tube placement after glaucoma drainage device (GDD) implantation.
The trial has fixed sample size with 12 months follow-up for primary outcome assessment and trial participants will continue to be followed to the end of grant cycle with a total of 24 months follow-up.
Patients will be randomized to 2 tube locations for GDD implantation:
* Tube placed in the AC
* Tube placed in ciliary sulcus
* Stratification: by clinical center and type of surgery (GDD alone vs GDD combined with phacoemulsification). Stratified randomization by clinical center is to ensure that a similar number of subjects will be randomized to either sulcus tube or AC tube placement for a specific clinical center. Because eyes undergoing a combined phacoemulsification with GDD implantation may be associate with larger ECL from phacoemulsification, stratified by surgery type is to ensure two tube location groups similar number of study eyes that will undergo a combined phacoemulsification with GDD implantation.
Eligibility criteria
Inclusion Criteria:
* Medically uncontrolled glaucoma requiring GDD or GDD combined with phacoemulsification as the planned surgical procedure
* Candidate for GDD implantation for ciliary sulcus and AC tube
* Age greater than or equal to 18 years old
Exclusion Criteria:
* Preexisting corneal condition that would affect the corneal endothelium or previous corneal transplant
* Presence or history of Cypass Micro-Stent
* Previous GDD, Xen Gel Stent or Preserflo MicroShunt removed less than 6 months before surgery
* Presence of GDD implantation, Xen Gel Stent, of Preserflo MicroShunt
* Previous trabeculectomy and/or minimally invasive glaucoma surgery within the past 6 months
* AC intraocular lens
* Presence of nanophthalmos, uncontrolled uveitis, silicone oil, Sturge-Weber syndrome or other conditions associated with elevated episcleral venous pressure
* Unwilling or unable to give consent, unwilling to accept randomization, or unable to return for scheduled protocol visits
* No light perception vision in the study eye or fellow eye visual acuity \< 20/200
* Need for glaucoma surgery combined with other ocular procedures (i.e. corneal transplant, or retinal surgery) or anticipated need for additional ocular surgery
Study design
Enrollment target: 226 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2023-07-11
Estimated completion: 2027-12
Last updated: 2025-06-27
Interventions
Procedure: Sulcus tube placementProcedure: Anterior chamber (AC) tube placement
Primary outcomes
- • Central endothelial cell loss (ECL) from baseline (Baseline to 12 months)
Sponsor
University of Pennsylvania · other
With: National Eye Institute (NEI), University of California, San Francisco, Stanford University
Contacts & investigators
ContactGui-shuang Ying, PhD · contact · gsying@pennmedicine.upenn.edu · 215-615-1514
InvestigatorYing Han, MD, PhD · study_chair, University of California, San Francisco
InvestigatorJennifer Rose-Nussbaumer, MD · study_director, Stanford University
InvestigatorThuy Doan, MD, PhD · study_director, University of California San Fransicso
All locations (8)
University of California San FranciscoRecruiting
San Francisco, California, United States
Diablo Eye AssociatesRecruiting
Walnut Creek, California, United States
Bascom Palmer Eye InstituteRecruiting
Miami, Florida, United States
Wilmer Eye Institute, Johns Hopkins UniversityRecruiting
Baltimore, Maryland, United States
Massachusetts Eye and EarRecruiting
Boston, Massachusetts, United States
University of Buffalo/State University of New YorkRecruiting
Buffalo, New York, United States
University of North Carolina at Chapel HillRecruiting
Chapel Hill, North Carolina, United States
Prism Eye Institute, University of TorontoRecruiting
Toronto, Canada